Preventing biofilm formation on implantable medical devices

Abstract

Biodegradable polymer-coated surgical meshes formed into pouches are described for use with cardiac rhythm management devices (CRMs) and other implantable medical devices. Such meshes are formed into a receptacle, e.g., a pouch or other covering, capable of encasing, surrounding and/or holding the cardiac rhythm management device or other implantable medical device and preventing or retarding the formation of a biofilm.

1. A method of retarding biofilm formation on an implantable medical device which comprises: (a) enveloping or covering said device, in whole or in part, in a polymer pouch comprising a polymer-coated mesh pouch comprising one or more resorbable polymers comprising tyrosine-based polyarylates coated on the mesh and including one or more antimicrobial agents in amounts effective to retard biofilm formation; and (b) implanting said enveloped device in a subject. 
     
     
       2. The method of  claim 1 , wherein the polymer-coated mesh pouch comprises one or more resorbable polymers coated on the mesh. 
     
     
       3. The method of  claim 1 , wherein the one or more antimicrobial agents inhibit biofilm formation by one or more of  Staphylococcus aureus, Staphylococcus epidermidis, Escherichia coli  or  Acinetobacter baummanii.    
     
     
       4. The method of  claim 2 , wherein the one or more antimicrobial agents inhibit biofilm formation by one or more of  Staphylococcus aureus, Staphylococcus epidermidis, Escherichia coli  or  Acinetobacter baummanii.    
     
     
       5. The method of  claim 1 , wherein said implantable medical device is a cardiac rhythm management device (CRMD), a neurostimulator, a pulse generator, a drug pump or infusion device, a physiological monitoring device, or a textured or smooth breast implant. 
     
     
       6. The method of  claim 5 , wherein the implantable medical device is a CRMD selected from the group consisting of a pacemaker, a defibrillator, an implantable cardioverter defibrillator (ICD), and a cardiac resynchronization therapy defibrillator (CRT device). 
     
     
       7. The method of  claim 1 , wherein said coating comprises two or more layers, and at least one layer of the coating comprises at least one antimicrobial agent and at least one biocompatible polymer. 
     
     
       8. The method of  claim 1 , wherein the at least one antimicrobial agent comprises rifampin and minocycline. 
     
     
       9. The method of  claim 2 , wherein the at least one antimicrobial agent comprises rifampin and minocycline. 
     
     
       10. The method of  claim 9 , wherein the amounts of rifampin and minocycline in the coating ranges from about 60-90 μg/cm 2  for each of rifampin and minocycline. 
     
     
       11. The method of  claim 10 , wherein the coating comprises about 0.5-1.0 mg resorbable polymer/cm 2 . 
     
     
       12. The method of  claim 9 , wherein the tyrosine-based polyarylates comprise a DTE-27.5% DT succinate polyarylate. 
     
     
       13. The method of  claim 11 , wherein the resorbable polymer is DTE-27.5% DT succinate polyarylate.